FDA.reportPublic FDA data

KOMET Spreader

Primary DI
E226006829A38
Brand
KOMET Spreader
Company
Gebr. Brasseler GmbH & Co. KG
Model
9107.654.050.A3
Catalog number
9107.654.050
Published
2023-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EKKSPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKKSpreader, Pulp Canal Filling Material, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E226006829A31PrimaryHIBCC0
E226006829A38Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, single-useA hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
317409001
Device count
6
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14053613296431Bur, Round, round shank08227360082273602026-05-04
14053613296646Bur, Round, round shank08227570082275702026-05-04
14053613295892Bur, Egg / egg shaped, round shank08227310082273102026-04-28
14053613296004Bur, Round, round shank08226860082268602026-04-28
14053613296325Bur, cylindrical, round shank08227240082272402026-04-28
14053613296363Bur, Bud / bud shaped, round shank08227280082272802026-04-28
14053613296455Bur, Round, round shank08227380082273802026-04-28
14053613296639Bur, Round, round shank08227560082275602026-04-28
14053613296684Twist drill, round shank08227620082276202026-04-28
14053613297438Bur, Round, round shank08228390082283902026-04-28
14053613297469Bur, Round, round shank08226770082267702026-04-28
14053613296561Bur, Round, round shank08227490082274902026-04-24
14053613296707Twist drill, round shank08227640082276402026-04-24
14053613295830Bur, Round, round shank08223830082238302026-04-21
14053613295878Bur, Round, round shank08226760082267602026-04-21
14053613295885Bur, Egg / egg shaped, round shank08227060082270602026-04-21
14053613295946Bur, Round, round shank08226800082268002026-04-21
14053613295953Bur, Round, round shank08226810082268102026-04-21
14053613295984Bur, Round, round shank08226840082268402026-04-21
14053613296035Bur, Round, round shank08226890082268902026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783009422Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009439Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009446Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009460Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009484Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009507Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009514Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009521Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009538Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009477Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-03-17
00348783009491Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-03-17
00840456213513JMUJMU DENTAL, INCEKK2025-08-18
00889813066867Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2025-03-12
00841013120435American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKK2025-02-18
00841013120442American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKK2025-02-18
00889813066843Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2024-11-30
00889813066850Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2024-11-30
00813677024480PDT, Inc.PDT, INC.EKK2024-06-27
00813677024985PDT, Inc.PDT, INC.EKK2024-06-27
08800075609809OSUNG MNDOSUNG MND Co., Ltd.EKK2024-03-04
08800075624048OSUNG MNDOSUNG MND Co., Ltd.EKK2024-03-04
06975718055359Denco Shenzhen Denco Medical Co., LtdEKK2023-12-27
06975718055366Denco Shenzhen Denco Medical Co., LtdEKK2023-12-27
06975718055373Denco Shenzhen Denco Medical Co., LtdEKK2023-12-27
06975718055380Denco Shenzhen Denco Medical Co., LtdEKK2023-12-27
D6919053814Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053816Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053818Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053820Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053826Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17